BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 4000E THYROID UPTAKE SYSTEM

    MDR report key: 10228437 · Received July 3, 2020

    Report

    Report Number
    2518443-2020-00001
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MIRION TECHNOLOGIES (CAPINTEC), INC.
    Product Code
    IZD
    UDI-DI
    00859942006102
    PMA / PMN Number
    CLASS I
    Removal / Correction Number
    RES 85237 Z-1564-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE LEAD NUCLEAR MEDICINE TECHNOLOGIST FROM (B)(6) CONTACTED CAPINTEC TO REPORT THAT THE COLLIMATOR DETACHED FROM THE SPRING ARM OF THEIR CAPTUS 4000E SYSTEM, S/N (B)(4). THE COLLIMATOR ASSEMBLY WEIGHS 28 POUNDS, AND THERE IS THE POTENTIAL FOR INJURY IF THE COLLIMATOR WERE TO FALL AND COME INTO CONTACT WITH A PATIENT OR OPERATOR. THE PATIENT WAS SEATED ON A CHAIR AND THE TECHNOLOGIST WAS PREPARING TO MEASURE THE PATIENT'S THYROID. THE TECHNOLOGIST WAS ABLE TO HOLD THE COLLIMATOR TO PREVENT IT FROM FALLING. NO INJURY OCCURED TO EITHER PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694015 CAPTUS 4000E THYROID UPTAKE SYSTEM THYROID UPTAKE SYSTEM IZD MIRION TECHNOLOGIES (CAPINTEC), INC. 5430-301542 NA 00859942006102

    Patients

    Seq Age Sex Outcome Treatment
    1